# K090782: Novel Alif Spinal Spacer System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Apr 22, 2009 after 30 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
134 later devices descend from it; 7 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K102402: Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System (2011), 112 descendants of its own
- K181453: ATEC ALIF Spacer System (2018), 111 descendants of its own
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own

## Indications for use
When used as an Intervertebral Body Fusion device, the Novel ALIF Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft. When used as a Vertebral Body Replacement device, the Novel ALIF Spinal Spacer System is intended for use in the thoracolumbar spine (Tl-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically-the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.

Source page: https://510kreport.com/device/K090782
Methodology: https://510kreport.com/methodology